Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
研究概览
简要总结
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
- •Has measurable or evaluable-only disease
- •Is female, ≥18 yrs of age, post menopausal or surgically sterile
- •HER2 negative, HR+, ER+ and/or PgR+ breast cancer
- •0-1 prior chemotherapy regimen for metastatic disease.
- •Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
- •Prior tamoxifen therapy is allowed
- •No AI therapy for >1 year without recurrence
排除标准
- •Pregnant or breast feeding
- •Prior hormonal therapy for metastatic or locally recurrent disease
- •>1 chemotherapy regimen for metastatic disease
- •Pleural or pericardial effusion
- •Serious cardiac condition
研究组 & 干预措施
A1
干预措施: Dasatinib (Drug)
A1
干预措施: Letrozole (Drug)
A2
干预措施: Letrozole (Drug)
结局指标
主要结局
Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population
时间窗: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.
次要结局
- Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population(At 6 months and at 12 months)
- Median Time to Treatment Failure (TTF) - ITT Population(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population(Day 1 to Study Completion (approximately 6 years))
- Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression(First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years))
- Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths(First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years))